The Cohort Study for Asthma in China

Capital Medical University

Status: Enrolling

Conditions: Asthma, Bronchial

Treatments: Diagnostic Test: Diagnostic Test: lung function test, chest CT, induced sputum, blood routine test, IgE test, FeNO test, six minutes walk test, questionnaires for asthma

Study type: Observational

Funder types: Other

Identifiers

NCT05937334

YJXBF202201

Details and patient eligibility

About

The study is to establish a standardized asthma cohort study, build an information network platform system and a biospecimen bank for asthma cohort, establish clear follow-up standards and norms, observe the asthma outcomes and identify biomarkers to predict asthma outcomes.

Full description

This is a single center observational prospective longitudinal cohort study to establish a standardized asthma cohort, consisting of 400 patients with asthma. Baseline data including lung function test, chest CT, induced sputum, etc. was collected and the patients were followed up for 2 or more years. Subjects who met the 2023 GINA diagnostic criteria for asthma and were able to participate in the study according to the protocol and sign the informed consent were included. No additional investigational drugs will be applied to the patients. Blood samples are transported to designated laboratories for safekeeping and biomarker testing. We aimed to explore the mechanism of biomarkers involved in asthma pathogenesis and identify treatable traits related to disease outcome. Full analysis set will be used for all analyses. Missing data will be analyzed as it is. Statistical analysis will be conducted by epidemiology & statistics work group from Chinese Academy of Sciences, using SAS and SUDAAN software. An electronic data capture system will be used in this study. Paper-based questionnaire administration will also be used. Questionnaire variables will be checked before data entry. During the study, PI will be in charge of the monitoring of the whole procedure. Working group will do the data cleaning and data analyzing.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18
• Meet the 2023 edition of GINA asthma diagnostic criteria
• Subjects must sign informed consent prior to study participation, participate in the study according to the protocol and follow up for 2 years

Exclusion criteria

• Suffering from other massive lung tissue destructive diseases such as severe bronchiectasis and tuberculosis
• Severe pleural disease and/or sternal and rib lesions
• Serious uncontrolled disease of other system
• Thoracic or abdominal surgery in the past 3 months
• Eye surgery in the past three months
• Retina detachment
• Myocardial infarction within the last 3 months
• Hospitalized for heart disease within the past 3 months
• Ongoing anti-tuberculosis treatment
• Pregnancy or breast feeding

Trial design